Assessment of SARS-CoV-2 IgG and IgM antibody detection with a lateral flow immunoassay test.
COVID-19
IgM and IgG
LFIA assay
SARS-CoV-2
Journal
Heliyon
ISSN: 2405-8440
Titre abrégé: Heliyon
Pays: England
ID NLM: 101672560
Informations de publication
Date de publication:
Oct 2021
Oct 2021
Historique:
received:
01
07
2020
revised:
19
03
2021
accepted:
13
10
2021
entrez:
25
10
2021
pubmed:
26
10
2021
medline:
26
10
2021
Statut:
ppublish
Résumé
The dramatic impact of SARS-CoV-2 infection on the worldwide public health has elicited the rapid assessment of molecular and serological diagnostic methods. Notwithstanding the diagnosis of SARS-CoV-2 infection is based on molecular biology approaches including multiplex or singleplex real time RT-PCR, there is a real need for affordable and rapid serological methods to support diagnostics, and surveillance of infection spreading. In this study, we performed a diagnostic accuracy analysis of COVID-19 IgG/IgM rapid test cassette lateral flow immunoassay test (LFIA) assay. To do so, we analyzed different cohorts of blood samples obtained from 151 SARS-CoV-2 RT-PCR assay positive patients (group 1) and 51 SARS-CoV-2 RT-PCR assay negative patients (group 2) in terms of sensitivity, specificity, PPV, NPV and likelihood ratios. In addition, we challenged LFIA with plasma from 99 patients stored during 2015-2017 period. Our results showed that this LFIA detected SARS-CoV-2 IgM and/or IgG in 103 out of 151 (68.21%) samples of group 1, whereas no IgM and/or IgG detection was displayed both in the group 2 and in pre-pandemic samples. Interestingly, IgM and/or IgG positivity was detected in 86 out of 94 (91.49%) group 1 samples collected after 10 days from symptoms onset whereas only 17 out of 57 of group 1 samples obtained before day 10 were positive to SARS-CoV-2 specific antibodies. We also compared the performance of this LFIA test with respect to other four different LFIA assays in 40 serum samples from multiplex RT-PCR positive individuals. Within the limits of the study size, the results demonstrated that COVID-19 IgG/IgM rapid test cassette LFIA assay displayed valid performance in IgM and IgG detection when compared with the other four LFIA assays. Hence, this approach might be considered as an alternative point-of-care procedure for SARS-CoV-2 serological investigation.
Identifiants
pubmed: 34693063
doi: 10.1016/j.heliyon.2021.e08192
pii: S2405-8440(21)02295-7
pmc: PMC8525011
doi:
Types de publication
Journal Article
Langues
eng
Pagination
e08192Informations de copyright
© 2021 The Author(s).
Références
J Virol Methods. 2019 Dec;274:113746
pubmed: 31568803
Cochrane Database Syst Rev. 2020 Jun 25;6:CD013652
pubmed: 32584464
Clin Infect Dis. 2020 Jul 28;71(15):793-798
pubmed: 32221523
JAMA. 2020 Mar 17;323(11):1061-1069
pubmed: 32031570
Nat Med. 2020 Jun;26(6):845-848
pubmed: 32350462
Front Med (Lausanne). 2021 Jan 14;7:560685
pubmed: 33521004
Eur Respir J. 2020 Aug 27;56(2):
pubmed: 32430429
J Clin Pathol. 2017 May;70(5):448-450
pubmed: 27864448
Diagn Microbiol Infect Dis. 2008 Aug;61(4):421-7
pubmed: 18455349
Pathogens. 2020 Mar 20;9(3):
pubmed: 32245083
Lancet. 2020 Feb 15;395(10223):497-506
pubmed: 31986264
J Microbiol Methods. 2014 Jan;96:12-5
pubmed: 24200707
Lancet. 2020 Feb 15;395(10223):507-513
pubmed: 32007143
J Clin Microbiol. 2020 May 26;58(6):
pubmed: 32245835
Clin Infect Dis. 2020 Nov 19;71(16):2027-2034
pubmed: 32221519
Nature. 2020 Mar;579(7798):270-273
pubmed: 32015507
Viruses. 2020 May 10;12(5):
pubmed: 32397688
J Clin Microbiol. 2020 May 26;58(6):
pubmed: 32229605
Lancet Infect Dis. 2020 May;20(5):565-574
pubmed: 32213337
Nature. 2020 Mar;579(7798):265-269
pubmed: 32015508
BMJ. 2015 Oct 28;351:h5527
pubmed: 26511519